title: Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines. AIDS Vaccine Evaluation Group, and the Correlates of HIV Immune Protection Group.
abstract: Among 2099 uninfected subjects in phase I and II trials of candidate AIDS vaccines, 23 were diagnosed with intercurrent human immunodeficiency virus type 1 (HIV-1) infection. High-risk sexual exposures accounted for 17 infections, and intravenous drug use accounted for 6. Four subjects received placebo, 13 received a complete immunization schedule (> or = 3 injections), and 6 were partially immunized (< or = 2 injections). There was no significant difference between vaccine recipients and control groups in incidence of HIV-1 infection, virus load, CD4 lymphocyte count, or V3 loop amino acid sequence. In summary, 19 vaccinated subjects acquired HIV-1 infection during phase I and II trials, indicating that immunization with the products described is < 100% effective in preventing or rapidly clearing infection. Laboratory analysis suggested that vaccine-induced immune responses did not significantly affect the genotypic or phenotypic characteristics of transmitted virus or the early clinical course of HIV-1 infection.
authors.affiliation: Vanderbilt University School of Medicine, Nashville, Tennessee 37232-2582, USA. barney.graham@mcmail.vanderbilt.edu
authors.forename: B S
authors.initials: BS
authors.lastname: Graham
authors.forename: M J
authors.initials: MJ
authors.lastname: McElrath
authors.forename: R I
authors.initials: RI
authors.lastname: Connor
authors.forename: D H
authors.initials: DH
authors.lastname: Schwartz
authors.forename: G J
authors.initials: GJ
authors.lastname: Gorse
authors.forename: M C
authors.initials: MC
authors.lastname: Keefer
authors.forename: M J
authors.initials: MJ
authors.lastname: Mulligan
authors.forename: T J
authors.initials: TJ
authors.lastname: Matthews
authors.forename: S M
authors.initials: SM
authors.lastname: Wolinsky
authors.forename: D C
authors.initials: DC
authors.lastname: Montefiori
authors.forename: S H
authors.initials: SH
authors.lastname: Vermund
authors.forename: J S
authors.initials: JS
authors.lastname: Lambert
authors.forename: L
authors.initials: L
authors.lastname: Corey
authors.forename: R B
authors.initials: RB
authors.lastname: Belshe
authors.forename: R
authors.initials: R
authors.lastname: Dolin
authors.forename: P F
authors.initials: PF
authors.lastname: Wright
authors.forename: B T
authors.initials: BT
authors.lastname: Korber
authors.forename: M C
authors.initials: MC
authors.lastname: Wolff
authors.forename: P E
authors.initials: PE
authors.lastname: Fast
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000328:Adult; D000595:Amino Acid Sequence; D018791:CD4 Lymphocyte Count; D005260:Female; D015483:HIV Antibodies / Q000032:analysis; D015699:HIV Envelope Protein gp120 / Q000032:analysis / Q000235:genetics; D015658:HIV Infections / Q000175:diagnosis* / Q000517:prevention & control* / Q000628:therapy; D015497:HIV-1; D006801:Humans; D007110:Immunity, Active; D015994:Incidence; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D009500:Neutralization Tests; D010446:Peptide Fragments / Q000032:analysis / Q000235:genetics; D012309:Risk-Taking; D017421:Sequence Analysis; D015819:Substance Abuse, Intravenous; D019562:Viral Load
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120; C059762:HIV envelope protein gp120 (305-321); D010446:Peptide Fragments